Ostomy pouch and high performance deodorizing gas filter assembly therefor

ABSTRACT

An ostomy pouch and high-performance gas filter assembly therefor, in which the filter assembly includes an envelope defining a filter chamber containing a radial flow deodorizing filter pad. The pad&#39;s opposite faces are joined to the inner surfaces of the envelope in such a way that the periphery of the pad is fully exposed within the chamber. A first passage extends through the filter and communicates with a first opening in a wall of the envelope over which a first microporous membrane extends. A second opening extends through the opposite wall of the envelope at a distance spaced laterally from the first opening, and a second hydrophobic microporous membrane extends over the second opening. In a preferred embodiment, the filter pad is oblong in shape and has a second passage spaced laterally from the first passage and communicating with the second aperture.

REFERENCE TO RELATED APPLICATIONS

This application is a Continuation under 35 U.S.C. § 120 of U.S. patentapplication Ser. No. 11/376,789, filed Mar. 16, 2006, now issued as U.S.Pat. No. 7,326,190, and claims the benefit under 35 U.S.C. § 119(e) fromU.S. Provisional Patent Application No. 60/684,600 filed May 25, 2005.

FIELD OF THE INVENTION

It is well known to provide ostomy pouches with deodorizing gas filtersso that flatus gases may be vented from the pouches to reduce or preventballooning and, at the same time, to deodorize the escaping gases.Typically, such a filter takes the form of disc or pad composed offibrous elements coated with finely-divided activated carbon particles,such a disc being secured to the wall of a pouch over a vent opening. Inan effort to prevent such a filter from becoming clogged and renderedineffective by liquid and/or solid body waste material within the pouch,it has been common either to secure the filter to the outside surface ofthe pouch over a vent opening or to provide protection for aninternally-mounted filter in the form of a porous membrane that extendsover the filter that is hydrophobic and may also be oleophobic.

Filters may be of the axial flow type or the so-called radial flow type,the latter term simply meaning that the gases flow along the plane of arelatively flat filter rather than directly or axially through thethickness of that filter. A filter of the radial or planar flow type isconsidered desirable because it allows for the construction of alow-profile filter that nevertheless provides an extended flow path fordeodorizing the flatus gases. While an extended flow path may bedesirable for deodorizing purposes, it also increases the resistance toflow and thereby reduces filter performance in terms of flow rate.Protective microporous membranes also adversely affect flow rate and, tocompensate for such resistance, membranes are often made larger in areathan the filters that they protect. Cost then becomes an issue becausethe membrane material may be a substantial portion of the total cost ofa deodorizing gas filter assembly and because the added production stepsnecessitated by including a protective membrane may further increase thecost of such an assembly.

Even when an internal filter is protected by a hydrophobic/oleophobicmicroporous membrane, liquid contact may still render a filterinoperative if, for example, the filter becomes saturated by water froman external source, as where an ostomate wears an ostomy pouch whiletaking a shower. In such a case, water may enter the filter through thevent opening in the wall of the pouch. Efforts have been made to reducesuch problems by making such openings in the form of S-shape slits (seeLaGro, U.S. Pat. No. 4,274,848), but it is recognized that suchconstructions do not completely solve the problem.

Other patents reflecting the state of the art are Nolan, et al., U.S.Pat. No. 3,759,260; Villefrance, U.S. Pat. No. 6,506,184; Lenz, U.S.Pat. No. 5,690,623; Keyes, U.S. Pat. No. 5,370,638; and Torgalkar, U.S.Pat. No. 5,250,043.

A main aspect of this invention therefore lies in providing ahigh-performance deodorizing gas filter assembly in which microporoushydrophobic (also selectively oleophobic) membranes protect the gasinlet located within a pouch and the gas outlet externally of the pouch.Despite the utilization of two such membranes, the filter assemblyachieves high performance in terms of an air transmission rate ofgreater than 4.5 cc/sec, preferably greater than 7.0 cc/sec, and morepreferably greater than 9.0 cc/sec, when such a filter of given area ismeasured at uniform pressure with a Gurley Densometer in conformancewith standard test procedures (ASTM D737-96, TAPPI 460, 536 and 251, andISO 5636/5). In terms of liquid repellency, the breakthrough pressurewhen subjected to a pressure increase no greater than 1.0 psi everythree seconds is greater than 4.7 psi, preferably greater than 8.0 psi,and more preferably greater than 10.0 psi. All of this is achieved withan assembly having high deodorizing efficiency (i.e., greater than 250min, preferable greater than 300 min, more preferably greater than 350min) when tested in conformance with standardized tests for hydrogensulfide in which 30.0 parts per million volume (ppmv) of the challengegas is contained in a stream of nitrogen. Crack pressure values shouldbe less than 1.0 psi, preferably less than 0.5 psi, and more preferablyless than 0.3 psi.

DRAWINGS

FIG. 1 is a rear (bodyside) elevational view of an ostomy pouch equippedwith a filter assembly embodying the present invention.

FIG. 2 is a front elevational view of the pouch.

FIG. 3 is a schematic sectional view taken along line 3-3 of FIG. 2 andshowing the various components of the filter assembly in explodedcondition.

FIG. 4 is a schematic view illustrating flow directions for the filterassembly.

FIG. 5 is an exploded cross-sectional view similar to FIG. 3, butillustrating a second embodiment of the invention.

FIG. 6 is a schematic view illustrating flow direction and filteringdimensions for the assembly of FIG. 5.

FIG. 7 depicts a modification of the assembly shown in FIGS. 5 and 6.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

FIGS. 1 and 2 illustrate an ostomy pouch 10 having front and rear walls11 and 12 joined along their edges by heat sealing 13 or by any othersuitable means. The pouch has a drain opening 14 that may be closed byfolding and/or clamping by any variety of known closure techniques, andrear wall 12 has a stoma-receiving opening 15 surrounded by attachmentmeans 16. In the illustration given, the pouch is one component of aso-called two-piece appliance and its attachment means takes the form ofa coupling ring having a channel for releasably engaging the matingelement of a faceplate coupling ring (not shown), all of which is wellknown in the art. Alternatively, the attachment means 16 may take theform of an adhesive ring or patch designed to adhesively engage theperistomal skin surfaces of a wearer (i.e., a one-piece appliance) orthe smooth surface of a faceplate which in turn is adhesively secured tothe wearer (an adhesive two-piece appliance).

FIG. 3 is an exploded and somewhat schematic sectional view showingfilter assembly 20. The assembly includes an envelope 21 having firstand second walls 22 and 23 of flexible thermoplastic film joinedtogether along the edges of first wall 22 to define a filter chamber 24.In the embodiment illustrated, the parts are secured together by heatseal 25, and the second wall 23 of the envelope is actually the frontwall 11 of the pouch. Alternatively, wall 23 may be a separate elementthat is joined to the inside surface of a pouches' front wall by anysuitable attachment means.

Within chamber 24 is a generally flat, porous filter pad 26 having apair of planar opposite faces 26 a and 26 b covered and sealed by gasimpermeable first and second thermoplastic films 27 and 28,respectively. The filter pad has a passage 29 extending axiallytherethrough, that is, in a direction normal or perpendicular to theplane of the filter. While the passage is shown to be cylindrical, itmay have other cross-sectional configurations than circular. The filteralso has an outer peripheral surface 30 concentric with passage 29 andfully exposed within chamber 24 of the envelope. That is, the peripheralsurface 30 is not occluded to any extent by wall 22 of the envelope.

Both the first film 27 and the second film 28 that cover opposite planarsurfaces of the filter pad 26 have openings 31 which, in the embodimentillustrated, are shown to be in registry with passage 29 and preferablysized to match the cross-sectional configuration of that passage.However, for purposes of this invention, it is essential only that thefirst film 27 be provided with such an opening. Thus, the second film 28may have no such opening, but may instead extend across the end ofpassage 29. A reason for providing openings 31 in both films is that atleast in some instances, it may facilitate production of the filterassembly.

The outer surfaces of films 27 and 28 are sealed to the inside surfacesof envelope walls 22 and 23 by heat seals 32 and 33 or by any othersuitable attachment means. It is essential that the seals 32 and 33extend 360° about the axis of passage 29 to prevent any possibility ofleakage of gas from that passage along the external surfaces of coverfilms 27 and 28.

The filter pad 26 may be manufactured using any of a variety of knowtechniques for making odor-absorbing ostomy pouch filters. One examplewould be a standard paper-making technique with fibers, usuallypolymeric, that are coated with finely-divided activated carbon using asuitable binder such as a conventional latex binder used in paper-makingprocedures. In general, the carbon should be finely-divided with themaximum size thereof being no greater than 100 microns, and with a sizedistribution in which more than one-half of the particles are less than50 microns in size. Alternatively, the pad may be composed of carbonizedviscous rayon textile, preferably arranged in a multiplicity of textilelayers as disclosed in U.S. Pat. No. 6,506,184, the disclosure of whichis incorporated by reference herein. For purposes of this invention, anyporous odor-absorbing filter material known for use in deodorizing theflatus gases vented from an ostomy pouch is believed suitable here.

Wall 22 of envelope 21 is provided with a first aperture or opening 34in communication with passage 29. A microporous gas-transmissible firstmembrane 35 extends over and across the aperture 34 and may be securedto the outer surface of wall 22 by a surrounding heat seal 36 or by anyother suitable means.

In the embodiment of FIG. 3, microporous membrane 35 should be bothhydrophobic and oleophobic to prevent liquids and solids from enteringpassage 29 from the interior of pouch 10. A number of materials suitablefor such use are commercially available, one being “Gore-Tex”, amicroporous polytetrafluoroethylene membrane marketed by W. L. Gore &Associates, Newark, Del. While different porosities for such a membranemay be suitable, it is preferred that the membrane have a pore sizeallowing passage through the membrane only of particles having a maximumdimension smaller than three microns, and more preferably two microns orless. Another material suitable for use as a microporous hydrophobic andoleophobic membrane is available from Millipore Corporation, Bedford,Mass., and is disclosed in U.S. Pat. No. 4,778,601 incorporated hereinby reference. Such a membrane is composed of microporous ultra highmolecular weight polyethylene.

Wall 23 of the envelope 21 is provided with a second aperture or opening37 spaced laterally from the first aperture 34 of wall 22. Morespecifically, in the embodiment of FIG. 3, the aperture 37 is locatedlaterally beyond the outer peripheral surface 30 of filter pad 26. Asecond microporous membrane 38 extends across opening 37 and is securedto the outer surface of wall 23 by a surrounding heat seal 39 or by anyother suitable sealing and attachment means. The material selected formembrane 38 may be the same as that used for membrane 35, such membranebeing both hydrophobic and oleophobic. However, it is also believedsuitable in the embodiment of FIG. 3 to use a microporous membrane thatis hydrophobic but does not have oleophobic properties. The reason isthat membrane 38 functions to protect chamber 24 and the filter thereinagainst exposure to water from an external source (e.g., a shower), andfor such purposes oleophobic properties may be unnecessary.

The directions of gas flow are indicated by arrows in FIGS. 3 and 4.Flatus gases from the interior pouch 10 pass through protectivemicroporous membrane 35 and enter passage 29 of the annular filter pad26. Filter 26 is of the radial flow type, so such gases then flow frompassage 29 radially outwardly, that is, outwardly along the plane of thefilter. The dimension of the flow path through the filter is representedby the letter “x” in FIGS. 3 and 4. The length of that flow path may beincreased or decreased as desired in order to achieve optimum filteringefficiency. After leaving filter 26, the deodorized gases pass outwardlythrough outlet opening 37 and microporous membrane 38.

It is to be noted that the gases may escape from the filter in anyradial or planar flow path extending 360° about the filter. This isschematically depicted in FIG. 4 where only the annular filter is shownin solid lines. Because the outer peripheral surface 30 of the filter isfully exposed within chamber 24 and is not occluded to any extent byenvelope wall 21, the gases may pass to outlet opening 37 by followingeither a direct route or by any other route over the range of 360° asindicated by the arrows.

The embodiment of FIG. 5 is similar to that of FIG. 3 except fordifferences in the construction of the filter. Hence, the numerals usedfor most of the parts are the same as those used in FIG. 3, anddiscussion of the composition, construction, and arrangement of likeparts will not be repeated.

Filter pad 126 is composed of the same filtering and odor-absorbingmaterial described for filter pad 26. Its planar opposite faces 126 aand 126 b are similarly provided with gas impermeable cover films 127and 128 secured to opposite faces of the pad, and annular heat seals 133and 141 then join the cover films to the wall 11 of the envelope.However, unlike the earlier pad, pad 126 is oblong or oval in outlineand has two flow passages 129 and 140, the latter being aligned with thesecond aperture (outlet opening) 37. As before, flatus gases enteringchamber 24 flow axially into passage 129 and then radially outwardlyover a range of 360° about the axis of passage 129. The most directroute to the second passage 140 is represented by dimension “x” in FIGS.5 and 6 which, for purposes of comparison, is the same distance “x”shown in FIGS. 3 and 4. It will be noted, however, that for an angulardistance of 180° about each cylindrical passage 129 and 140 of theoblong pad 126, the radial dimension is shown to be only ½ “x”.Nevertheless, the shortest flow path through the filter pad from thefirst aperture (inlet opening) 34 to the second aperture (outletopening) 37 remains “x” because any gases exiting the filter through the½ “x” dimension must again re-enter the filter, now flowing radiallyinwardly, for another distance of ½ “x”, to enter the second passage140. In FIGS. 5 and 6 it will be noted that the shortest dimension fromeach of the passages 129 and 140 to the periphery of the filter is atleast ½ “x” because of the oval symmetry of the filter but, whether thefilter is symmetrical or non-symmetrical (e.g. pear-shaped in outline),the essential requirement is that the sum of the shortest distancesbetween the respective passages and the periphery of the filter be noless than “x”.

FIG. 7 is a schematic view similar to FIG. 6, but showing that an oblongfilter pad 126′ might be rectangular rather than oval in shape. Theoperation is otherwise identical with the minimum (i.e. direct) flowpath from passage 129′ to 140′ still being “x”. The passages might be ofgenerally circular cross-section as in FIG. 6 or the may be of othercross-sectional shapes. Square cross-sections are depicted in FIG. 7.Whatever the cross-sectional shape selected, the shortest flow pathbetween each passage 129′ and 140′ and the outer periphery of the filterpad is shown in FIG. 7 to be at least ½ “x”. Thus, the sum of theshortest distances to the pad's outer periphery from the two passagesconsidered together should be at least “x”.

The embodiment of FIG. 7 might be advantageous to that of FIG. 6 forproduction reasons, since the filter 126′ might be cut from stockwithout wastage. Also, the embodiments of FIGS. 5 to 7 are believed tohave some advantages over the embodiment of FIGS. 3 and 4 in terms ofease of production and because the oblong (generally rectangular, oroval) shape of the filter allows the filter to perform a furtherfunction as a uniform spacer between the walls 22 and 23 of theenvelope, thereby preventing or reducing the possibility that such wallsmight directly contact or block against each other.

While it is essential that the filters of the embodiments so fardescribed be of the radial or planar flow type, it is not required(although perhaps preferable) that the filters be located within thepouch 10. Thus, referring to the embodiment of FIG. 3, filter 26 and itsenvelope 21 might be located outside the pouch 10 with the filter pad 26positioned within the envelope at the second aperture (outlet opening)37. In such a case, the first aperture 35 would function as the inletopening. Both apertures would again be protected by microporoushydrophilic membranes, but in such an arrangement it would be the secondmembrane 38 at the second aperture (inlet) 37 that would be required tobe oleophobic as well as hydrophobic, whereas the first membrane 35 atthe first aperture (outlet) 34 might only be hydrophobic. In such anembodiment, the gas flow through the filter 26, while radial, would bejust the reverse of what is shown in FIG. 3, that is, the flow would beradially inwardly from the periphery rather than radially outwardly fromthe filter's central passage.

Similarly, the envelope 22 shown in FIG. 5 might be located externallyof the pouch 10 but, as shown by the arrows in that figure, the flow ofgasses would continue to be first in a radially outward direction fromthe first passage and then in a radially inward direction into thesecond passage. The result, in each and all of the embodiments, is afilter assembly which, despite its radial flow operation (which involvesan extended flow path in relation to conventional axial-flow ostomypouch filters), and despite the provision of two protective membranesfor such filter, may nevertheless be of distinctively high-performancemeasured in terms of minimum gas transmission rate, liquid repellency orhold out, and deodorization capability. Allowing for differences in thecompositions and dimensions of the filters and the inlet and outletmembranes, it is found that the assemblies disclosed herein are capableof air transmission rates greater than 4.5 cc/sec., preferably greaterthan 7.0 cc/sec., and more preferably greater than 9.0 cc/sec. whenmeasured in conformance with standard procedures such as ASTM D737-96,TAPPI 460, 536 and 251, and ISO 5636/5. In such a test, a GurleyDensometer (Model 4110) is used to measure porosity or air-resistance ofsheet-like materials. The test measures the time for the flow of astandard volume of air (e.g. 100 cc) to pass through a standard area (1sq. in) under uniform pressure. More specifically, an air-filledcylinder is pressurized by a 20 oz. piston and, when the air isreleased, timers automatically measure the time for 100 cc of air topass through the filter. Data is generally captured in seconds andconverted into measured flow rates of cc/sec of air.

Further, such a filter assembly embodying this invention is capable ofliquid hold-out or repellency, of greater than 4.7 psi, preferablygreater than 8.0 psi, and more preferably greater than 10 psi whentested to measure the liquid pressure at which liquid will first breakthrough such a filter. In such a procedure, the specific liquid used isde-ionized water, soap and dye (blue in color). The filter assembly isclamped over a liquid chamber such that the filter assembly is visible.Liquid pressure is increased under the filter assembly at a rate nogreater than 1.0 psi every 3 seconds until breakthrough is visuallyobserved (at a distance of 12 in) on the filter surface opposite theliquid chamber. The pressure at which breakthrough is first visuallyobserved is then recorded as the breakthrough pressure.

It has also been found that crack pressure, that is, the minimumpressure needed to produce air flow through the filter assemblies ofthis invention, should be less than 1.0 psi, preferably less than 0.5psi, and more preferably less than 0.3 psi.

As to deodorizing capability, the assemblies of this invention withstanda transmission of odors, when measured using hydrogen sulfide gas in anitrogen stream, for periods greater than 250 min, preferably greaterthan 300 min, and more preferably greater than 350 min using hydrogensulfide as the challenge gas. Such a procedure is commonly used toevaluate the performance of activated carbon ostomy filters for theremoval of a challenge gas (hydrogen sulfide) from a stream of nitrogen.A nitrogen stream containing 30.0 ppmv hydrogen sulfide is passedthrough an ostomy filter until a 1.0 ppmv breakthrough of hydrogensulfide is detected. After passing through the ostomy filter, thenitrogen stream is analyzed for the presence of the challenge gas every12 minutes. The time to reach the stated post-filtering hydrogen sulfidegas concentration level is then recorded. Proper nitrogen flow of 250cc/min is verified prior to each ostomy filter test, and the nitrogenflow is analyzed for the presence of the challenge gas by means of gaschromatography with a flame photometric detector (FPD).

While radial-flow ostomy pouch filters have been known in the past,including assemblies having protective microporous membranes therefor,applicant is unaware of any such filter assembly with dual membranesthat has been marketed, or is being marketed, achieving both the airtransmission levels and the hold-out levels of the filter assemblies ofthis invention, much less any prior filter assembly that also has thedeodorizing capabilities and the crack pressure characteristicsdescribed above.

The term “radial flow” has been used throughout this application torefer to the flow through a flat ostomy filter in directions parallelwith its planar faces, in contrast to a flow direction directly throughthe thickness of that filter which is considered as axial flow. Thus,“radial” refers to a direction toward or away from a passage extendingthrough the thickness of the filter and is not limited to filters inwhich such passages are circular in cross-section. As disclosed above,such passages may be of square cross section or any other suitablecross-section.

1. An odor-absorbing gas filter assembly for body waste collectionpouches, comprising an envelope having first and second walls offlexible thermoplastic film joined together along edges to define afilter chamber; a porous radial flow filter pad with activated carbontherein located within said chamber and having a pair of planar oppositefaces; said pad having a passage extending therethrough from one face tothe other and having an outer peripheral surface fully exposed withinsaid filter chamber; said opposite faces being joined respectively tothe inner surfaces of the first and second walls of said envelope toblock the axial flow of gases through said filter; said first wall ofsaid envelope having a first aperture communicating with said passage; afirst microporous gas-transmissible membrane of hydrophobic materialsealed to said first wall about said first aperture and extending oversaid first aperture to prevent liquids from entering said passage andsaid filter pad; said second wall of said envelope having a secondaperture spaced laterally from said first aperture; and a secondmicroporous gas-transmissible membrane of hydrophobic material sealed tosaid second wall about said second aperture and extending over saidsecond aperture to prevent liquids external to said envelope fromentering said chamber.
 2. The assembly of claim 1 in which gas may flowradially 360 degrees about said passage between said passage and saidfilter's outer peripheral surface.
 3. The assembly of claim 2 in whichsaid flow is radially outwardly.
 4. The assembly of claim 2 in whichsaid flow is radially inwardly.
 5. The assembly of claim 2 in which saidfilter pad is annular in shape and said outer peripheral surface isconcentric with said cylindrical passage.
 6. The assembly of claim 1 inwhich said second aperture is spaced laterally from said outerperipheral surface of said filter pad.
 7. The assembly of claim 1, 2 or6 in which one of said membranes is an inlet membrane and the other ofsaid membranes is an outlet membrane; said inlet membrane, andoptionally said outlet membrane, being of a material that is oleophobicas well as hydrophobic.
 8. The assembly of claim 1 in which said filterassembly has an air transmission rate greater than 4.5 cc/sec and aliquid hold-out greater than 4.7 psi.
 9. The assembly of claim 8 inwhich said filter assembly has deodorization barrier properties of morethan 250 minutes when tested with a challenge gas of hydrogen sulfide.10. The assembly of claim 9 in which said filter assembly has a crackpressure less than 1.0 psi.
 11. A body waste collection pouch havingfront and rear walls joined together along their peripheral edges; saidrear wall having a stoma-receiving opening externally surrounded byattachment means for securing said pouch to a wearer; an odor-absorbinggas filter assembly within said pouch comprising an envelope havingfirst and second walls of flexible thermoplastic film joined togetheralong edges to define a filter chamber; a porous radial flow filter padcontaining activated carbon located within said chamber and having apair of planar opposite faces; said pad having an inlet passageextending therethrough from one face to the other and having an outerperipheral surface fully exposed within said filter chamber; one of saidfaces being covered by a gas-impermeable first film having an openingcommunicating with said passage and the other of said faces beingcovered by a gas-impermeable second film; said first and second filmsbeing sealed respectively to the inner surface of the first and secondwall of said envelope; said first wall of said envelope having an inletopening communicating with said opening of said first film and saidinlet passage; a microporous gas-transmissible inlet membrane ofhydrophobic and oleophobic material sealed to said first wall about saidinlet opening and extending over said inlet opening to prevent liquidsand solids from entering said inlet passage; said second wall of saidenvelope having an outlet opening spaced laterally from said opening ofsaid first wall; and a microporous gas-transmissible outlet membrane ofhydrophobic material sealed to said second wall about said outletopening and extending over said outlet opening to prevent liquidsexternal to said envelope from entering said chamber.
 12. The pouch ofclaim 11 in which said second wall of said envelope comprises a portionof one of said walls of said pouch.
 13. The pouch of claim 11 in whichsaid filter pad is annular in shape and said outer peripheral surface isconcentric with said passage.
 14. The pouch of claim 12 in which saidoutlet opening is spaced laterally from said outer peripheral surface ofsaid filter pad.
 15. The assembly of claim 8 in which said filterassembly has an air transmission rate greater than 7.0 cc/sec and aliquid hold-out greater than 8.0 psi.
 16. The assembly of claim 8 inwhich filter assembly has an air transmission rate greater than 9.0cc/sec and a liquid hold-out greater than 10 psi.
 17. The assembly ofclaim 8 in which filter assembly has deodorizing barrier properties ofmore than 300 minutes when tested with a challenge gas of hydrogensulfide.
 18. The assembly of claim 8 in which said filter assembly hasdeodorizing barrier properties of more than 350 minutes when tested witha challenge gas of hydrogen sulfide.
 19. The assembly of claim 10 inwhich said filter assembly has a crack pressure less than 0.5 psi. 20.The assembly of claim 10 in which said filter assembly has a crackpressure less than 0.3 psi.